The purpose of this study is to evaluate the safety and tolerability of intravitreal injection of ONL1204 Ophthalmic Solution in patients with geographic atrophy associated with AMD. GA associated with AMD is one of the world's leading causes of visual disability. It is a progressive disease with no approved therapy to slow or arrest the process of continual photoreceptor and retinal epithelial (RPE) cell loss. A safe and effective therapy for GA will have vast societal benefits. ONL1204 is being developed for this purpose. ONL1204 is a first-in-class inhibitor of fragment apoptosis stimulator receptor-mediated cell death in development for to reduce rates of vision in patients with GA associated with AMD. ONL1204 has demonstrated protection of multiple retinal cell types in several preclinical models of acute ocular injury and the protection of RPE in AMD models. ONL1204 Ophthalmic Solution is currently in a Phase 1 clinical study in patients with macula-off retinal detachment to evaluate safety and tolerability of a multi-dose of ONL1204 Ophthalmic Solution. The study is ongoing and uses the same doses and route of administration as this Phase 1b study in patients with GA.
In this study patients will be enrolled and followed for 24 weeks (natural history phase) at which point they will be randomized to 1 of 2 doses of ONL1204 Ophthalmic Solution or sham. Weeks 24 to 48 make up the Treatment Phase. Patients will be on study for a total of 48 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
28
Liquid formulation administered by intravitreal (IVT) injection
sham injection is done by touching the eye surface with a syringe without a needle
Chatswood Retina
Chatswood, New South Wales, Australia
Retina and Eye Consultants Hurtsville
Hurstville, New South Wales, Australia
Retinology Institute
Glen Iris, Victoria, Australia
Queensland Eye Institute
Melbourne, Victoria, Australia
Center for Eye Rearch Australia
Melbourne, Victoria, Australia
Sunshine Eye Surgeons
St Albans, Victoria, Australia
Eye Institute Limited
Remuera, Auckland, New Zealand
Southern Eye Specialists
Christchurch, New Zealand
Best Corrected Visual Acuity
ETDRS chart (number of letters read)
Time frame: up to 48 weeks
Intraocular pressure
Intraocular pressure recorded in mmHg
Time frame: up to 48 weeks
Slit lamp biomicroscopy
Slit lamp using US FDA clinical grading scale 0-4; 0=normal, 4=very severe changes)
Time frame: up to 48 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.